KlokUpdate 18-DEC-2019: The EU parliament adopted the second MDR corrigendum, giving manufacturers of Class I medical devices 4 years extra to bring their clinical evaluation in order, putting them in the same position as the other medical devices with a valid CE certificate.

With only half a year left until application, the implementation of EUDAMED delayed with 2 years, and slow progress on implementation of acts and guidances, there are calls for and rumors on extension of timelines of the EU MDR. But does that actually mean that medical device manufacturers have more time to bring their clinical evaluation in order?

Under the MDR all devices will require a Clinical Evaluation with clinical evidence

“appropriate in view of the characteristics of the device and its intended purpose”

including Class I devices.

Medical devices with valid CE certificates can be placed on the market under the current EU Directives as well as the new regulation during the transition period of the MDR. This means that CE certificates issued under the current Directives will remain valid for a period of four years post date of issue, so until 25th May 2024, unless there is a significant product update (then a clinical evaluation per MDR is needed).CE

Does that mean that for devices with a valid CE certificate there is plenty of time to update their clinical evaluation? The answer is that that depends on the device and the concerning clinical evaluation plan, since under the current directives manufacturers are required to actively update clinical evaluations

“.. when the manufacturer receives new information from PMS that has the potential to change the current evaluation; if no such information is received, then at least …. every 2 to 5 years if the device is not expected to carry significant risks and is well established”

so best case the manufacturer with devices in this category has time until the certificate expires.

LaidBackA laid back attitude towards product clinical evidence collection, however, is not advisable, since these manufacturers are in the fortunate situation they still have time to gather their own clinical evidence in a postmarket setting, which currently (changes are in progress everywhere though!) is still less complex than in a premarket setting, and might be a necessary evil since the equivalence pathway has become much harder under the MDR as technical, biological, and clinical

“characteristics shall be similar to such an extent that there would be no clinically significant difference in the clinical performance and safety of the device. Considerations of equivalence must always be based on proper scientific justification. Manufacturers must be able to clearly demonstrate that they have sufficient levels of access to the data on devices to which they are claiming equivalence in order to justify that claimed equivalence.”

More problematic is the situation for

class I medical devices since they have no CE certificate and will have to comply with the MDR and update all technical information including clinical evidence by May 26, 2020. Manufacturers of Class I devices may still self-certify, as long as MDR requirements are satisfactorily met, BUT an extra complicating factor is that several Class I devices have been up-classified to Class IIa, IIb or even Class III (including some health apps), SleepApnoeAppand the requirements with respect to pre- (and postmarket) clinical evidence are more strict under the current directives as well as the MDR.

Now, news is circulating for some time now that a second Corrigendum is in preparation, potentially introducing a transitional period for up-classified class l devices, including class I reusable devices, but, although projected for this month, thus-far unconfirmed as far as I am aware. So manufacturers better not bet on that, and, products with a valid CE certificate aside, all devices are still in the same boat as far as timelines for updating their clinical evaluation are concerned.

In conclusion, do medical device manufacturers have more time to update their clinical evaluation? Thus-far the answer is no, as nothing changed in that respect since the clarifying interpretation of the MCDG in beginning this year, and for the majority of devices the deadline of May 26th, 2020 still applies. So at this moment the key question is more whether 6 months will be enough to build or strengthen the clinical evidence base, if not already started working on it? For a full blown clinical investigation it typically will be too short (also refer to a previous post addressing time needed for a clinical trial), but when using alternative sources for your clinical evaluation it might just be tight, and key is to act NOW.

Feel free reaching out in case of questions regarding the above, or support needed concerning your clinical evaluation.


About Annet Muetstege - Visscher

My name is Annet Muetstege and I am a clinical research expert, based in The Netherlands, with over 25 years of experience in all aspects of clinical evidence planning and execution especially in medical devices. I am the co-founder of Applied Clinical Services.
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  1. Pingback: 2020 – THE 11th HOUR FOR THE MDR, ISO 14155, & OTHER EU CLINICAL MATTERS | Medical Devices Clinical

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